Kornimate/medical-research-clean huggingface dataset:
the toby children study

Conditions: Cerebral Palsy; Hypoxia-Ischemia, Brain

Summary: the aim of this study is to determine the efficacy of therapeutic hypothermia following perinatal asphyxia on neurological and neuropsychological outcomes and also to assess academic attainment and any additional health, societal or educational costs associated with changes in outcome as a result of the intervention. this study will determine whether the apparent initial benefits of cooling are maintained in the longer term. perinatal asphyxia (a lack of oxygen occurring around the time of birth) may have long term consequences on brain functioning, which may be altered by treatment with hypothermia (cooling). currently, there is no information on the effect of cooling on outcome beyond 18 months of age. we intend to assess at 6 - 7 years of age, the children that participated in the toby trial of whole body cooling following perinatal asphyxia and compare between the children that had received the cooling treatment soon after birth and those that were not treated with cooling, the number that survived with an intelligence quotient (iq) greater than 84, the presence and severity of disabilities, educational attainment and the economic impact on families and service providers. if possible, children will be assessed in their school, with the option of alternative venues such as home or clinic if required. during the assessment a paediatrician will conduct a neurological examination. a psychologist will administer psychometric tests to evaluate cognitive, behavioural and motor development. questionnaires completed by parents and teachers will complete the data collection. economic factors will also be assessed in the parent questionnaire. each child will have contact with the assessors during one school day with appropriate breaks. assessments will take place over a period of 3 years.

* assessment tools used: * wechsler preschool and primary scale of intelligence third edition (wppsi-iii; 2004) or wechsler intelligence scales for children * nepsy second edition * working memory test battery for children * neurological examination by paediatrician * questionnaire data from parents/guardians and teachers

Eligibility criteria:
inclusion criteria: * participant in the toby study exclusion criteria: * previously documented instruction not to approach for inclusion in further toby projects
femoral neck locking plate vs multiple cannulated cancellous screws in treatment of femoral neck fractures in young adults: randomized controlled clinical trial study

Conditions: Femoral Neck Fractures

Summary: fracture neck femur are common injuries, especially seen in the elderly in the emergency setting. it is also seen in young patients with high-energy trauma. immediate diagnosis and management are required to prevent threatening joint complications. fracture neck femur in young adults is unsolved problem. the preservation of the native hip anatomy and biomechanics is essential in active young adults. because of the vulnerable blood supply to the femoral part of the hip joint following these fractures, there is a high risk of developing avascular necrosis (avn) and non-union. any sort of surgical fixation should aim at preservation the blood supply while securing enough mechanical stability until the fracture unites. open reduction is indicated in fractures which cannot be anatomically reduced by gentle manipulation. this should be carried out without any delay since this potentially can reduce the incidence of avn. treatment of fracture neck femur still controversial. there are several methods for treatment of fracture neck femur as multipe cannulated cancellous screws, locking plate, dynamic hip screw (dhs) with anti-rotational screw, and arthroplasty. there is no internal fixation method superior to another. in this study, we will compare the clinical and radiographic results of femoral neck locking plate vs multiple cannulated cancellous screw in treating femoral neck fractures in young adults.


Eligibility criteria:
inclusion criteria: * patients (20-55) years * having unilateral traumatic femoral neck fracture * idependent walker before trauma without any aids exclusion criteria: * open fracture * pathological fracture * preexisting deformity * other pelvic or ipsilateral femoral injuries * renal impairment or were on high dose steroids
amplatzer™ cardiac plug observational post-approval study

Conditions: Non-valvular Atrial Fibrillation (NVAF)

Summary: the purpose of this study is to observe the safety and effectiveness of the amplatzer™ cardiac plug (acp) device in chinese population indicated for use of amplatzer™ cardiac plug after its market approval by china fda (cfda). this is a prospective, multi-centre, single arm, post approval, observational study. the clinical study will be conducted at up to 35 sites in china. approximately 343 subjects will be enrolled in this study. the total study duration is expected to be approximately 7 years. the study population included patients who have non-valvular atrial fibrillation (nvaf) and are contraindicated to long-term oral anticoagulant; or patients who experience stroke or other thromboembolic event despite taking warfarin. scheduled office visits occur at 45 days (+45 days), 6m (+/- 3 weeks) 12m (+/- 6 weeks) and 24 m(+/- 6 weeks) post procedure; phone contact follow up visits occur at, 36 m (+/- 6 weeks), 48m (+/- 6 weeks) and 60 m (+/- 6 weeks) post procedures.


Eligibility criteria:
inclusion criteria: 1. patient who meets the current indications and per physician discretion for acp implant 2. patient who is ≥ 18 years of age at the time of enrolment 3. patient who is able to provide written informed consent prior to any study related procedures exclusion criteria: 1. patient who is unable to comply with the follow-up schedule 2. patient with the presence of intracardiac thrombus 3. patient with active endocarditis or other infections producing bacteraemia 4. patient who has low risk of stroke (cha2ds2-vasc score is 0 or 1) or low risk of bleeding (has-bled score\<3) 5. patient where placement of the device would interfere with any intracardiac or intravascular structures 6. patient who is under medical conditions not appropriate to participate in the study in the opinion of the investigator 7. patient with laa anatomy that does not accommodate a device per the sizing guidelines 8. patient who has a life expectancy of less than 2 years due to any condition 9. patient who are currently participating in a clinical investigation that includes an active treatment arm 10. patient who already had a left atrial appendage closure device implanted prior to the study

Keywords: non-valvular atrial fibrillation (nvaf) anticoagulant warfarin stroke
proclaim: germline genetic testing for prostate cancer patients

Conditions: Prostate Cancer

Summary: this registry is for men who have prostate cancer and have had multigene panel hereditary testing. the registry will gather data on genetic testing results and how that information may change physician treatment or follow up recommendations. it will also gather data on the patient's experience with genetic testing, through a post-test survey to be completed 60-90days after results have been received and discussed with their provider.

this registry will enroll men with prostate cancer who have done multi-gene testing for their cancer. patients will be enrolled into two cohorts, one for individuals who meet current nccn testing guidelines, and one for individuals who do not meet current nccn guidelines. the main goal of this registry is to assess whether nationally developed guidelines used to select patients for hereditary testing are adequate to identify all patients with prostate cancer who may benefit from testing. patients will completed a post-test survey regarding their testing experience and clinicians will be asked to provide additional medical records review information via the clinician report form.

Eligibility criteria:
inclusion criteria: * men ages 18-90 who have been prescribed genetic testing as part of their clinical care * have prostate cancer at any stage, either actively under treatment or being followed who either: 1. meet nccn criteria for testing or 2. do not meet nccn criteria for testing * patients who are naive to clinical genetic testing for brca1/brca2 (single gene panel testing) exclusion criteria: * mental or cognitive impairment that interferes with ability to provide informed consent
natural gels for treatment of plaque psoriasis

Conditions: Parapsoriasis

Summary: the aim of the study is to evaluate the safety and the therapeutic activity of the combination of natural gel combination and hair mask of plant origin in patients with mild to moderate plaque psoriasis.

this is a random, double blind placebo -vehicle- controlled study. patients recruiting and inclusion into the study is well defined. expert on site monitoring will assure execution of all assignments as detailed in the protocol (screening, consent form, double-blind group assignment) . statistical analysis: * it is calculated that 52 patients will be needed for this study. * type i error probability associated with this test is 0.05 . * uncorrected chi square will be used to assess changes in the measured variables.

Eligibility criteria:
inclusion criteria: 1. subjects with stable (for at least 6 months), mild to moderate (less than 10% of the skin surface area) plaque psoriasis. 2. male and female ≥ 18 years old. 3. subject is capable of giving a written informed consent. exclusion criteria: 1. subjects treated by topical or photo or systemic anti psoriatic therapy during 4 weeks prior to the study. 2. subjects treated with biological products for psoriasis for the last 3 months prior to starting the present study. 3. subjects with any other type of psoriasis but vulgaris (plaque ). 4. use of investigational agents \< 30 days prior to the study. 5. low compliance. 6. subjects who are mentally or physically unable to comply with all aspects of the study. 7. pregnant women. 8. known allergic reaction to fragrance or any ingredient of the test products. 9. other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis. 10. a medical condition that may put the patient at a general risk and therefore would prevent participation in the clinical trial.
neurofeedback as a treatment for trauma-affected refugees

Conditions: Post Traumatic Stress Disorder

Summary: neurofeedback (nf) is a form of treatment that can assist individuals in learning to control their brain wave activity. nf-studies have shown promising results in reducing pstd-symptoms among military veterans, but there are no published peer-reviewed studies with refugees. however, preliminary studies from malmö and sydney indicate that refugees could benefit from nf. therefore, at the competence centre for transcultural psychiatry (ctp) a longitudinal feasibility study, testing nf for trauma-affected was started. the study contains both a quantitative and a qualitative substudy. in in the quantitative substudy, where a total of 32 participants have been included, the aim was to evaluate the feasibility of nf with trauma affected refugees using a quantitative perspective. the nf intervention offered was 12 training sessions of 12-20 minutes nf, and the outcome measures were self-administered questionnaires and semi-structured interviews collected before and after the intervention. in a subsample of eight participants of those included in the quantitative substudy, qualitative in-depth interviews were carried out. the participants were offered two interviews; one before the first nf training and one during the treatment course. the aim of the qualitative substudy was to evaluate the feasibility of nf with trauma-affected refugees by examining the participants' thoughts and expectations prior to participating in nf treatment as well as their experience with the treatment after a few sessions.


Eligibility criteria:
inclusion criteria: * refugee or a person who had been family reunified with a refugee * diagnosed with ptsd (icd-10 diagnosis f43.1) and experienced a psychological trauma in another country than denmark. * informed consent. exclusion criteria: * current abuse of drug or alcohol (f1x.24-f1x.26) * diagnosed with a severe psychotic disorder (f2x) or a manic disorder (f30.1-f31.9). * no informed consent.

Keywords: neurofeedback refugee trauma qualitative study
pilot study testing feasibility of health screening at farm site

Conditions: Diabetes Screening; Hyperlipidemia Screening; Hypertension Screening

Summary: test the feasibility of performing worksite screening of hypertension, diabetes and hyperlipidemia for six months

the investigators will be visiting farmers at the worksite monthly for six month and perform cardiovascular risk factors screening: blood pressure, blood glucose, glycosylated hemoglobin and cholesterol. at the end of this intervention, the investigators will test the feasibility of this approach among this specific population through questionnaires.

Eligibility criteria:
inclusion criteria: * 18 years and older * agricultural workers and farm owners exclusion criteria: * none

Keywords: worksite screen migrant agricultural worker hypertension hyperlipidemia diabetes feasibility
unknown cause of acute liver failure

Conditions: Liver Failure; Unknown Etiology

Summary: the purpose of the study is to evaluate the outcome and to determine predictive factors of patients admitted in a context of acute liver failure without identified cause.

methodology: multicentric french national cohort with prospective collection of data and constitution of biobank, in patients hospitalized in a context of acute liver failure without known cause at admission. follow-up during 3 months for each patients. the primary objective is to determine predictive factors of early mortality. this study is an observational cohort and patients will received standard care during the follow-up.

Eligibility criteria:
inclusion criteria: * acute liver failure defined by a pt\ 1.5; * with or without hepatic encephalopathy; * without cause identified at admission, and non a non b hepatitis; * age\>18 year old; * signed an informed consent. exclusion criteria: * chronic liver disease; * patient under guardianship

Keywords: liver failure etiology liver transplantation
daily imaging, target identification, and simulated computed tomography-based stereotactic adaptive radiotherapy workflow in a novel ring gantry radiotherapy device

Conditions: Cancer of Pancreas; Cancer of Pelvis; Cancer of Abdomen; Cancer of Thorax

Summary: the investigators propose here to evaluate the feasibility of a novel cone-beam ct (cbct)-guided online adaptive radiotherapy (art) workflow on the halcyon device.


Eligibility criteria:
inclusion criteria: * at least one disease site deemed to be suitable for simulated treatment with online adaptive radiotherapy per radiation oncology evaluation. * scheduled to receive radiation therapy to the thorax (n = 8), pancreas (n = 8), non-pancreas abdomen (n = 8), or pelvis (n = 8). * at least 18 years of age * able to understand and willing to sign an irb-approved written informed consent document. exclusion criteria: * pregnant and/or breastfeeding. women of childbearing potential must have a negative pregnancy test within 14 days of study entry. if pregnancy test is not clinically indicated as determined by treating physician or protocol pi, documentation of this exception is sufficient in lieu of a pregnancy test.
phlogenzym® in patients with acute thrombophlebitis - efficacy and tolerance

Conditions: Thrombophlebitis Leg

Summary: oral enzyme therapy in patients with acute superficial vein inflammation (thrombophlebitis) can serve as an additional treatment option besides standard therapy with compression stockings, common pain medication and physical treatments. this randomized, double-blinded trial compares efficacy and safety with placebo.

enzymes are absorbed in the small intestine and taken up into the bloodstream, at least to some extent. there, they act in an anti-inflammatory manner, as was first described for the serine protease trypsin. similarly, the cysteine protease bromelain, extracted from the stems of pineapples, is an effective phytotherapeutical drug with anti-inflammatory properties.proteases have also been indicated to show a certain improvement of the fluidity of the blood. an additional component of the oral enzyme combination can be rutoside, or rutin, a flavonoid known to have cytoprotective and anti-inflammatory properties.

Eligibility criteria:
inclusion criteria: * male ог female patients with thrombophlebitis in the upper extremities (with ог without varicosis); * age \~ 18 years; * acute thrombophlebitis in the lower leg * moderate to severe pain as monitored on a visual analog scale (vas, value ≥ 3 cm) * pain under pressure * presence of at least three of the following symptoms: skin redness, hyperthermia, phlebitic cords, feeling of heaviness and tenseness. exclusion criteria: * known deep phlebothrombosis * flourishing ulcus cruris * arterial occlusive disease * peripheral neuropathy * malignant disease * concomitant concomitant treatment ог а therapy which ended less than 7 days before baseline with corticosteroids, diuretics, anticoagulative agents, platelet aggregation inhibitors and systemic/topical use of anti-inflammatory agents, other preparations for veins and analgesics; * known intolerance against the active ог the inactive ingredients of the study medication (especially lactose); * pregnancy * lactation, * known alcohol or drug abuse * participation in another clinical study

Keywords: thrombophlebitis
the effects of freshwater clam extract on blood sugar, and lipid profile in prediabetes patients

Conditions: Prediabetes; Metabolic Diseases; Glucose Metabolism Disorders; Dietary Supplement; Nutrition

Summary: the purpose of this study is to determine whether the freshwater clam extract and its combination is effective on the improvement of glucose and lipid metabolism, also evaluate its ability to postpone prediabetes patients to become diabetes.

this study aims to evaluate the effect of freshwater clam extract and its combination is effective on the improvement of glucose and lipid metabolism, as well as evaluate its ability to postpone prediabetes patients to become diabetes., 3 month and 6 month data will be collected and put into analysis to provide some suggestions on the clam protein capsules and clam peptide plus chlorella capsules use in the clinical practice for prediabetes patients.

Eligibility criteria:
inclusion criteria: 1. agree to cooperate in the trial and sign the written informed consent 2. age 25-70 years 3. glucose ac between 100-125 mg/dl 4. hba1c between 5.7%\~6.4% 5. total cholesterol≧160mg/dl or ldl-c≧100mg/dl remark: meet one of the (3)\~(5) conditions is acceptable exclusion criteria: 1. pregnant and lactating women 2. poor medication compliance 3. abnormal liver function patients (alt and ast value\> 2 folds of normal value upper limit ) 4. abnormal renal function patients (creatinine value\>1.5 mg/dl) 5. abnormal gastrointestinal function patients (eg. gastrostomy, enterostomy, and diarrhea) 6. sever comorbidity in the last 6 months. (eg. brain stroke, myocardial infarction, and major trauma and surgery) 7. using influence blood sugar, blood pressure, and blood lipid drugs (eg sex hormones, corticosteroids, h2 blockers, diuretics and statin ) 8. diabetes patients 9. other sever diseases ( malignant tumor and alzheimer's disease) 10. with inflammatory diseases, infectious disease, and severe immune deficiency ( eg. tuberculosis, aids, active pneumonia, systemic lupus erythematosus and rheumatoid arthritis) 11. other influence blood sugar endocrine disease (eg. hyperthyroidism, acromegaly, cushing's syndrome and pheochromocytoma)

Keywords: prediabetes glucose metabolism disorders metabolic diseases clam protein capsules clam peptide clam amino capsules clam extract
examining new diagnostic tests for acute kidney injury after heart surgery

Conditions: Kidney Failure, Acute; Renal Insufficiency

Summary: people who undergo coronary artery bypass grafting (cabg) or heart valve surgery may experience acute kidney injury (aki) after their surgery. current medical tests cannot identify aki until approximately 48 hours after it occurs. this study will examine three new biomarkers in blood and urine that may provide a more effective and faster way of predicting aki in people who undergo cabg or heart valve surgery.

aki, which is indicated by a sudden change in serum creatinine levels, is a serious complication that can occur after a patient undergoes cabg or heart valve surgery. people who experience aki after heart surgery may be at increased risk for post-operative complications, including long-term kidney failure or heart damage. aki is currently identified by testing serum creatinine levels in the blood, which is the traditional marker of kidney function. however, serum creatinine levels can be affected by other non-kidney-related factors and may not positively identify aki until 48 hours after it begins. this study will examine three new biomarkers found in urine and blood-urine interleukin 18 (il-18), neutrophil gelatinase-associated lipocalin (ngal), and cystatin c-that may be able to predict aki more effectively and faster than serum creatinine levels. in addition, study researchers will also determine if changes in these biomarkers can predict the severity of aki more successfully than serum creatinine tests. this study will enroll people undergoing cabg or heart valve surgery at yale-new haven hospital. before the surgery and once a day for 5 days after the surgery, blood and urine collection will occur. study researchers will also review participants' medical records. twelve months after hospital discharge, participants will return to the clinic for a follow-up visit for repeat blood and urine collection and to complete questionnaires. a portion of blood will be saved for future genetic testing; this is optional.

Eligibility criteria:
inclusion criteria for adults: (must have at least one of the following) * emergent surgery * pre-existing kidney impairment (baseline serum creatinine greater than 2 mg/dl) * ejection fraction less than 35% * at least 70 years old * diabetes mellitus * combined cabg and valve surgery * repeat cabg or valve surgery exclusion criteria for adults: * pre-operative acute kidney injury * enrolled in a conflicting research study * prior kidney transplantation * baseline serum creatinine level greater than 4.5 mg/dl * nephrotoxic drugs administered pre-operatively * surgery for only left ventricular assist device inclusion criteria for children: * undergoing open heart surgery exclusion criteria for children: * pre-existing acute kidney failure (greater than 50% decline in creatinine clearance)

Keywords: acute kidney injury il-18 ngal cystatin c biomarkers dialysis